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Home » FDA Clears New Indications for Lyme Disease Diagnostics

FDA Clears New Indications for Lyme Disease Diagnostics

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July 30, 2019

The FDA has OK’d four diagnostic tests with new indications for diagnosing Lyme disease.

“The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially” rather than the current two-step Western Blot test, the agency said.

The new assays are easier to interpret in the laboratory due to the streamlined methods for running the tests, CDRH said.

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